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The study overcomes limitations in prior studies in that it (1) assessed personal characteristics before study entry in order to exclude "contamination" effects, (2) selected an appropriate control group, and (3) differentiated between STEM and non-STEM study majors.
Specifically, the slope of PSA after study entry was significantly lower than that before study entry in 6 patients and the slope of PSA after study entry was significantly higher than before study entry in 2 patients.
Of the 20 patients, the slope of PSA after study entry was significantly lower than that before study entry in 6 patients, significantly higher than that before study entry in 2 patients, and unchanged in the remaining 12 patients.
The recurrence of dysglycemia suggests the possibility that dysglycemia could have occurred before study entry in some individuals.
Changes in PSA after study entry were compared to that before study entry in terms of doubling time.
The slopes of PSA after study entry were compared to that before study entry in a mixed regression model as described in the statistical analysis section.
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PSA doubling times were positive in all patients (median = 15 months) before study entry, i.e. PSA levels at study entry were higher than the initial PSA levels.
The present exploratory analysis examined the efficacy, safety, and quality-of-life effects of everolimus (EVE) + exemestane (EXE) in the subgroup of patients in BOLERO-2 whose last treatment before study entry was in the (neo)adjuvant setting.
As in our study, 83% of the patients had a disease duration of less than 6 months; our data on the occurrence of sick leave in the 12 months before study entry suggest that in a considerable proportion of patients, sick leave may occur before they enter an EAC, and a diagnosis of arthritis has been made.
A washout period of 28 days before study entry was applied in those patients who were receiving topical high-potency corticosteroids, phototherapy (including artificial tanning beds), and disease-modifying antirheumatic drugs other than methotrexate.
Patients might have had any number of prior systemic therapy, radiotherapy or surgery, but therapies had to be discontinued at least 4 weeks before study entry (6 weeks in case of mitomycin C and nitrosoureas).
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